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FDA 510(k)

HEEL/ELBOW PROTECTOR

K-Number: K771913 · 1977-11-15

ApplicantAlba-Waldensian, Inc.
Decision Date1977-11-15
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEEL/ELBOW PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Alba-Waldensian, Inc.. It received FDA 510(k) clearance on 1977-11-15 under 510(k) number K771913. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEEL/ELBOW PROTECTOR?

HEEL/ELBOW PROTECTOR is a medical device that received FDA 510(k) clearance on 1977-11-15. The listed applicant is Alba-Waldensian, Inc.. The 510(k) number is K771913.

When did HEEL/ELBOW PROTECTOR receive FDA 510(k) clearance?

HEEL/ELBOW PROTECTOR received FDA 510(k) clearance on 1977-11-15, under 510(k) number K771913.

Who is the listed applicant for HEEL/ELBOW PROTECTOR?

The FDA 510(k) record lists Alba-Waldensian, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEEL/ELBOW PROTECTOR?

The FDA product code for HEEL/ELBOW PROTECTOR is FMP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Alba-Waldensian, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K020592ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001K961405ALBA HEALTH PAS WRAP SYSTEMK852091ALBA DRY BURN PADK792357STERILE IMPERVIOUS ORTHOPEDIC STOCKINK781964COMPRESSION DEVICES, LIMBK780570TUBULAR DRESSING RETAINER

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Related Devices (Code: FMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.K811184SPENCO DERMAL PADSSpenco Medical Corp.K802829SCANLAN VASCU-STATTScanlan Intl., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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